1. Field of the Invention
This invention relates to means for taking body cavity recordings of pressure and of electromyography (EMG) during electrical stimulation for the principal purpose of properly fitting a patient with an electrical stimulator treatment device and also for diagnosing and monitoring of treatment. While this disclosure relates to use in body cavities broadly, it is principally used intravaginally or intrarectally.
Urinary incontinence is a common problem throughout the world and is particularly prevalent in the female population and in the aged. Resulting from incontinence is embarrassment, significant patient discomfort and distress, loss of sleep and the necessity for large monetary disbursements by the patient for absorbent pads, diapers, rubber sheeting and for cleaning of soiled clothing. Currently, treatments of choice consist of surgery, physical exercises and drug therapy.
Functional electrical stimulation has shown promise as an alternative treatment and the same is of course noninvasive, safe in use and relatively inexpensive. The use of intravaginal, intrarectal and transcutaneous electrical stimulation has been known for over fifteen years both in the United States and in Europe and the mechanisms of action are fully documented and well known.
Electrical stimulation of the various branches of the pudendal nerve which lead to the muscles of the pelvic floor have been found to cause contraction of these muscles acutely and strengthening of the muscles during chronic stimulation. With adequate and timely electrical stimulation in this manner, the patient may be completely cured of incontinence and may no longer require further assistance or treatment. It may however require many months of stimulation to reach this result.
There are also reflex pathways involving the pudendal, parasympathetic, sympathetic and somatic nerves which converge on the micturition center of the body located in the spinal cord to produce bladder inhibition and pelvic floor sphincter contraction, both urinary and anal. These known stimulating devices may be employed for both stress-type incontinence with pelvic floor weakness and urge-type incontinence with bladder hyper-irritability, or even mixtures of these two types.
It has also been found that such stimulators are effective in the treatment of certain sexual dysfunctions which are common in these patient populations with similar nerve pathway problems. These include erectile and ejaculatory problems in the male and functional problems including infertility in the female.
2. Prior Art
Examples of electrical stimulation devices for use in the treatment of incontinence and sexual dysfunction are found in the following U.S. Pat. Nos.: 3,518,997-Sessions, 3,623,486-Berkovitz, 3,631,860-Lopin, 4,102,344-Conway et al., 4,569,351-Tang, 4,577,640-Hofmeister, and 4,515,167-Hochman.
Typical prior art devices include an elongated cylindrical intravaginal insert or vehicle formed from electrical insulating material which is substantially rigid and of such a size as to fit completely within the vagina. Two or more electrodes encircle the insert and are spaced apart along the length thereof and are connected via a wire running internally of the insert to a source of electrical potential. The positioning of the electrodes is critical and they must be in the proper location to contact the appropriate area on vaginal wall so that the stimulation activates the pelvic floor muscle. This position is also critical so that it activates reflex pathways. The electrical signal applied to the electrodes is usually in the form of a plurality of pulses of relatively short duration.
When these devices are activated, the stimulator produces a series of electrical pulses transferred by the electrodes to the vaginal wall adjacent to the desired muscles causing contraction of these muscles of the pelvic floor. As a result thereof, the external sphincter of the urethra is constricted, preventing the undesired outward flow of urine.